IL-17 Antibody Clears Psoriasis

Brodalumab, a monoclonal antibody that targets the interleukin (IL)-17 receptor, was effective in moderate-to-severe plaque psoriasis in a phase III study, Amgen and AstraZeneca announced.

The trial's primary endpoint, a 75% improvement in the Psoriasis Area Severity Index (PASI 75) at week 12, was achieved by 83.3% of patients receiving a higher dose of brodalumab and by 60.3% of those given a lower dose, compared with 2.7% of patients on placebo.

In addition, the percentage of patients who had at least 90% improvement were 70.3%, 42.5%, and 0.9% in the three groups, respectively, while 41.9%, 23.3%, and 0.5% showed 100% improvement.

Brodalumab is a human monoclonal antibody that inhibits inflammatory signaling through the IL-17 pathway.

The trial, known as AMAGINE-1, included 661 patients who initially were randomized to receive subcutaneous brodalumab in dosages of 210 mg or 140 mg or placebo every 2 weeks.

After 3 months, those given the active treatment whose physician ratings were "clear" or "almost clear" skin were re-randomized to continue treatment or to receive placebo.

Patients who were re-randomized and worsened were then given their initial dose, and any patient initially given placebo or not re-randomized subsequently was then given the 210-mg dose every 2 weeks.

The most common adverse events were nasopharyngitis, headache, and upper respiratory tract infections.

"Data from the AMAGINE-1 study suggest that brodalumab may offer a new level of efficacy for patients with moderate-to-severe plaque psoriasis, a disease that affects more than 100 million people globally," Sean E. Harper, executive vice president of research and development at Amgen, said in a statement.

In an earlier phase 2 trial reported in the New England Journal of Medicine, patients given 140 mg or 210 mg of brodalumab showed a mean improvement in PASI scores after 3 months of 85%. Among those receiving the 210-mg dose, 82% had a PASI 75 response and 75% had a PASI 90 response, as did 77% and 72% of those receiving the 140-mg dose.

In contrast, no patients receiving placebo had PASI 75 or 90 responses.

Two other phase III studies in psoriasis are ongoing. In AMAGINE-2 and -3, safety and efficacy of various doses of brodalumab are being compared with ustekinumab (Stelara).

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